Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy

Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy

The single-arm phase II CAVE mCRC trial evaluated the combination of cetuximab plus avelumab as rechallenge strategy in <i>RAS</i> wild-type (WT) metastatic colorectal cancer (mCRC) patients, with clinical response to first-line anti-EGFR-based chemotherapy, who progressed and received a...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Davide Ciardiello, Vincenzo Famiglietti, Stefania Napolitano, Lucia Esposito, Nicola Normanno, Antonio Avallone, Tiziana Latiano, Evaristo Maiello, Filippo Pietrantonio, Chiara Cremolini, Giuseppe Santabarbara, Carmine Pinto, Teresa Troiani, Erika Martinelli, Fortunato Ciardiello, Giulia Martini
Formato: article
Lenguaje:EN
Publicado: MDPI AG 2021
Materias:
rechallenge anti-EGFR
immunotherapy
skin toxicity
mCRC
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Acceso en línea:https://doaj.org/article/644e2914914c48e9b39e0f6cb9eac8c7
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:644e2914914c48e9b39e0f6cb9eac8c7
record_format dspace
spelling oai:doaj.org-article:644e2914914c48e9b39e0f6cb9eac8c72021-11-25T17:03:06ZSkin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy10.3390/cancers132257152072-6694https://doaj.org/article/644e2914914c48e9b39e0f6cb9eac8c72021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/22/5715https://doaj.org/toc/2072-6694The single-arm phase II CAVE mCRC trial evaluated the combination of cetuximab plus avelumab as rechallenge strategy in <i>RAS</i> wild-type (WT) metastatic colorectal cancer (mCRC) patients, with clinical response to first-line anti-EGFR-based chemotherapy, who progressed and received a subsequent line of therapy. The correlation of skin toxicity (ST) and different clinico-molecular variables with overall survival (OS), progression-free survival (PFS) and response rate (RR) was assessed at univariate and multivariate analysis. A total of 33/77 (42.9%) patients experienced grade 2–3 ST and displayed median OS (mOS) of 17.8 months (CI 95%, 14.9–20.6); whereas 44/77 (57.1%) patients with grade 0–1 ST exhibited mOS of 8.2 months (CI 95%, 5.5–10.9), (hazard ratio (HR), 0.51; CI 95%, 0.29–0.89; <i>p</i> = 0.019). Median PFS (mPFS) was 4.6 months (CI 95%, 3.4–5.7) in patients with grade 2–3 ST, compared to patients with grade 0–1 ST with mPFS of 3.4 months (CI 95%, 2.7–4.1; HR, 0.49; CI 95%, 0.3–0.8; <i>p</i> = 0.004). Grade 2–3 ST (HR, 0.51; CI 95%, 0.29–0.89; <i>p</i> = 0.019) and <i>RAS/BRAF/EGFR</i> WT circulating tumor DNA (ctDNA) (HR, 0.50; CI 95%, 0.27–0.9; <i>p</i> = 0.019) had a statistically significant effect on OS at univariate analysis. At the multivariate analysis, <i>RAS/BRAF/EGFR</i> WT ctDNA status maintained statistical significance (HR, 0.49; CI 95%, 0.27–0.9; <i>p</i> = 0.023), whereas there was a trend towards ST grade 2–3 (HR, 0.54; CI 95%, 0.29–1.01; <i>p</i> = 0.054). Skin toxicity is a promising biomarker to identify patients with mCRC that could benefit of anti-EGFR rechallenge.Davide CiardielloVincenzo FamigliettiStefania NapolitanoLucia EspositoNicola NormannoAntonio AvalloneTiziana LatianoEvaristo MaielloFilippo PietrantonioChiara CremoliniGiuseppe SantabarbaraCarmine PintoTeresa TroianiErika MartinelliFortunato CiardielloGiulia MartiniMDPI AGarticlerechallenge anti-EGFRimmunotherapyskin toxicitymCRCNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5715, p 5715 (2021)
institution DOAJ
collection DOAJ
language EN
topic rechallenge anti-EGFR
immunotherapy
skin toxicity
mCRC
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle rechallenge anti-EGFR
immunotherapy
skin toxicity
mCRC
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Davide Ciardiello
Vincenzo Famiglietti
Stefania Napolitano
Lucia Esposito
Nicola Normanno
Antonio Avallone
Tiziana Latiano
Evaristo Maiello
Filippo Pietrantonio
Chiara Cremolini
Giuseppe Santabarbara
Carmine Pinto
Teresa Troiani
Erika Martinelli
Fortunato Ciardiello
Giulia Martini
Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
description The single-arm phase II CAVE mCRC trial evaluated the combination of cetuximab plus avelumab as rechallenge strategy in <i>RAS</i> wild-type (WT) metastatic colorectal cancer (mCRC) patients, with clinical response to first-line anti-EGFR-based chemotherapy, who progressed and received a subsequent line of therapy. The correlation of skin toxicity (ST) and different clinico-molecular variables with overall survival (OS), progression-free survival (PFS) and response rate (RR) was assessed at univariate and multivariate analysis. A total of 33/77 (42.9%) patients experienced grade 2–3 ST and displayed median OS (mOS) of 17.8 months (CI 95%, 14.9–20.6); whereas 44/77 (57.1%) patients with grade 0–1 ST exhibited mOS of 8.2 months (CI 95%, 5.5–10.9), (hazard ratio (HR), 0.51; CI 95%, 0.29–0.89; <i>p</i> = 0.019). Median PFS (mPFS) was 4.6 months (CI 95%, 3.4–5.7) in patients with grade 2–3 ST, compared to patients with grade 0–1 ST with mPFS of 3.4 months (CI 95%, 2.7–4.1; HR, 0.49; CI 95%, 0.3–0.8; <i>p</i> = 0.004). Grade 2–3 ST (HR, 0.51; CI 95%, 0.29–0.89; <i>p</i> = 0.019) and <i>RAS/BRAF/EGFR</i> WT circulating tumor DNA (ctDNA) (HR, 0.50; CI 95%, 0.27–0.9; <i>p</i> = 0.019) had a statistically significant effect on OS at univariate analysis. At the multivariate analysis, <i>RAS/BRAF/EGFR</i> WT ctDNA status maintained statistical significance (HR, 0.49; CI 95%, 0.27–0.9; <i>p</i> = 0.023), whereas there was a trend towards ST grade 2–3 (HR, 0.54; CI 95%, 0.29–1.01; <i>p</i> = 0.054). Skin toxicity is a promising biomarker to identify patients with mCRC that could benefit of anti-EGFR rechallenge.
format article
author Davide Ciardiello
Vincenzo Famiglietti
Stefania Napolitano
Lucia Esposito
Nicola Normanno
Antonio Avallone
Tiziana Latiano
Evaristo Maiello
Filippo Pietrantonio
Chiara Cremolini
Giuseppe Santabarbara
Carmine Pinto
Teresa Troiani
Erika Martinelli
Fortunato Ciardiello
Giulia Martini
author_facet Davide Ciardiello
Vincenzo Famiglietti
Stefania Napolitano
Lucia Esposito
Nicola Normanno
Antonio Avallone
Tiziana Latiano
Evaristo Maiello
Filippo Pietrantonio
Chiara Cremolini
Giuseppe Santabarbara
Carmine Pinto
Teresa Troiani
Erika Martinelli
Fortunato Ciardiello
Giulia Martini
author_sort Davide Ciardiello
title Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
title_short Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
title_full Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
title_fullStr Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
title_full_unstemmed Skin Toxicity as Predictor of Survival in Refractory Patients with <i>RAS</i> Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy
title_sort skin toxicity as predictor of survival in refractory patients with <i>ras</i> wild-type metastatic colorectal cancer treated with cetuximab and avelumab (cave) as rechallenge strategy
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/644e2914914c48e9b39e0f6cb9eac8c7
work_keys_str_mv AT davideciardiello skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT vincenzofamiglietti skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT stefanianapolitano skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT luciaesposito skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT nicolanormanno skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT antonioavallone skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT tizianalatiano skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT evaristomaiello skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT filippopietrantonio skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT chiaracremolini skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT giuseppesantabarbara skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT carminepinto skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT teresatroiani skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT erikamartinelli skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT fortunatociardiello skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
AT giuliamartini skintoxicityaspredictorofsurvivalinrefractorypatientswithirasiwildtypemetastaticcolorectalcancertreatedwithcetuximabandavelumabcaveasrechallengestrategy
_version_ 1718412779103191040

Ejemplares similares